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YY/T 0923-2014 English PDF (YYT0923-2014)

YY/T 0923-2014 English PDF (YYT0923-2014)

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YY/T 0923-2014: Needleless accedd ports for fluid lines and blood lines. Test method for microbial ingress

This Standard specifies the test method for microbial ingress of needleless access ports for liquid lines and blood lines.
YY/T 0923-2014
PHARMACEUTICAL INDUSTRY STANDARD
ICS 11.080.01
C 31
Needleless access ports for fluid lines and blood lines -
Test method for microbial ingress
ISSUED ON. JUNE 17, 2014
IMPLEMENTED ON. JULY 01, 2015
Issued by. China Food and Drug Administration
Table of Contents
Foreword... 3
Introduction... 4
1 Scope... 5
2 Normative references... 5
3 Terms and definitions... 5
4 Test principle... 5
5 Apparatus and reagents... 5
6 Test strains... 6
7 Sampling... 6
8 Test methods... 6
9 Report... 8
Needleless access ports for fluid lines and blood lines -
Test method for microbial ingress
1 Scope
This Standard specifies the test method for microbial ingress of needleless access ports for liquid lines and blood lines.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. YY 0581.2, Infusion access adapter - Part 2.Needleless access adapters
3 Terms and definitions
Terms and definitions given in YY 0581.2, as well as the following term, apply to this document.
3.1
Microbial ingress
The process in which microorganisms enter the sterile liquid lines or blood lines through the needleless access ports during use.
4 Test principle
Inoculate microorganisms of specified type and quantity to the needleless access port; disinfect the access port according to the disinfection procedure provided by the manufacture; then, use a sterile syringe to inject sodium chloride injection of specified volume through the access port; collect the downstream effluent for cultivation and count.
5 Apparatus and reagents
5.1 Filtering device, equipped with a sterile filter bowl.
8.1.2 For each selected test strain, take test samples respectively and operate according to 8.2 ~ 8.4.
8.1.3 The operations of 8.2.1 ~ 8.2.4 for the test sample group shall be carried out continuously.
8.2 Test sample group
8.2.1 Inoculation
Inoculate 0.01 mL of bacterial suspension to each test sample access port in a sterile manner, and let it dry.
8.2.2 Disinfection
Sterilize and dry the access ports of the test samples according to the disinfection procedure1) provided by the manufacturer.
8.2.3 Injection
Use a sterile syringe to draw 10 mL of sodium chloride injection; connect the sample access port and perform a Luer lock; then, inject 10 mL of sodium chloride injection through the access port.
8.2.4 Cultivation and count
Collect the downstream effluent of each sample, and carry out membrane filtration respectively; place the filter membrane on the TSA plate with the bacteria face up. Place the TSA plate in a constant temperature incubator at 30 ??C ~ 35 ??C for 3 d ~ 7 d; observe the colony growth daily; count the number of colonies.
8.2.5 Repeated test
For each sample, repeat the operations of 8.2.1 ~ 8.2.4 twice more; then, repeat the operation of 8.2.3 continuously, until there are 3 more times before the maximum number of uses indicated by the manufacturer (if any) or the number of uses determined by the maximum number of days of use indicated by the manufacturer2) (whichever is greater); finally, repeat the operations of 8.2.1 ~ 8.2.4 for three times. 8.2.6 Recording of results
Record the results of cultivation and count of each test sample during each operation of 8.2.1 ~ 8.2.4.
8.3 Positive control group
1) The regulations on disinfection procedure provided by the sanitation management agency - if any - shall be carried out accordingly.
2) Calculated by multiplying the maximum days of use by 8.If the sanitation management agency has regulations on the maximum days of use, it shall be calculated according to the maximum days of use.

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